MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number L331

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 02/06/2024

Event Type  Injury  

Event Description

It was reported that this pacemaker was part of a system revision due to infection.There were no additional adverse patient effects reported.The pacemaker remains in service.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this pacemaker was part of a system revision due to infection.There were no additional adverse patient effects reported.The pacemaker remains in service.Additional information indicates that the pacemaker was explanted due to infection.Reportedly, pus was coming out of the pocket area due to infection.There were no additional adverse patient effects reported.

Manufacturer Narrative

This supplemental report was created to update the entry in d6b: explant date, h6: patient codes and h6: impact codes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACCOLADE MRI EL DR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18758992
• MDR Text Key: 336005600
• Report Number: 2124215-2024-10599
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 622838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male